2024-512571-12-00招募中4 期
Oil- versus water-based contrast media for hysterosalpingography (HSG) in infertile women with unevaluated indications: a randomized controlled trial (H2Oil-2 study)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 499
- 试验地点
- 9
- 主要终点
- The primary outcome is conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization.
研究概览
简要总结
Conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment Phase
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ovulation disorders (ovulation disorders will be defined as less than 8 menstrual cycles per year)
- •High risk for tubal pathology (high risk for tubal pathology will be defined as a positive chlamydia infection, a pelvic inflammatory disease, known endometriosis, abdominal surgery (including tubectomy for ectopic pregnancy and appendectomy) and/or peritonitis in the medical history)
- •Above 38 years of age
排除标准
- •Iodine allergy
- •Male subfertility defined as a post-wash total motile sperm count < 1 x10^6 spermatozoa/ml
- •Not willing or able to sign the consent form
- •Endocrine disorders as diabetes, hyperthyroidism or hyperprolactinemia (except for well managed hypothyroidism with TSH between 0.3 and 2.5mIU/l)
结局指标
主要结局
The primary outcome is conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization.
The primary outcome is conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization.
次要结局
- Biochemical pregnancy
- Clinical pregnancy
- Ongoing pregnancy
- Miscarriage
- Ectopic pregnancy
- Multiple pregnancy
- Time to pregnancy
- Complications following HSG (infection, intravastion)
- Pregnancy outcomes (f.e. birth weight)
- Pregnancy complications
- Stillbirth
- Thyroid function of the woman (before and 1 month after HSG)
- Neonatal outcomes
- Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI)
- Costs within 6 months after randomization
- Thyroid function of neonate (determined by heelprick)
研究者
Prof. dr. V. Mijatovic
Scientific
Amsterdam UMC Stichting
研究点 (9)
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